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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH CLS SPORTORNO STEM

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ZIMMER GMBH CLS SPORTORNO STEM Back to Search Results
Model Number N/A
Device Problem Appropriate Term/Code Not Available
Event Date 12/18/2019
Event Type  Injury  
Manufacturer Narrative

The manufacturer did receive x-rays, operative and lab reports for review. The manufacturer did not receive the device for investigation. As no lot number was provided, the device history records could not be reviewed. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. (b)(4).

 
Event Description

Patient was implanted on the left side and underwent revision surgery due to pain, abductor insufficiency with corresponding limp.

 
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Brand NameCLS SPORTORNO STEM
Type of DeviceCLS SPORTORNO STEM
Manufacturer (Section D)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
Manufacturer (Section G)
ZIMMER GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key9921000
Report Number0009613350-2020-00163
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 04/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/25/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 04/03/2020 Patient Sequence Number: 1
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